Clovis ends mid-stage trial of bladder cancer drug Rubraca citing probable lack of clinical benefit

Clovis Oncology disclosed in a US Securities and Exchange Commission filing on Friday that it is discontinuing the Phase II ATLAS trial testing Rubraca (rucaparib) monotherapy in recurrent metastatic bladder cancer. The company said upon review of preliminary data for 62 patients, an independent data monitoring committee concluded that the objective response rate in the intent-to-treat population indicates the treatment "may not provide a meaningful clinical benefit." 

Clovis noted that the decision was not based on safety concerns. The drugmaker said it will continue to assess the use of Rubraca in combination with other treatments for use in patients with advanced bladder cancer. It also plans to enrol patients with advanced bladder cancer and selected genetic mutations in a pan-tumour trial of Rubraca slated to start in the second half of the year. 

Rubraca initially received accelerated approval by the FDA in 2016 for the treatment of certain women with advanced ovarian cancer, and was later cleared in Europe for the same indication. The PARP inhibitor has also been authorised in the US and EUfor the maintenance treatment of recurrent ovarian cancer. 

Earlier this month, Clovis presented Phase II study results demonstrating that Rubraca led to complete or partial responses in several patients with advanced BRCA- or PALB2-mutated pancreatic cancer. For related analysis, see ViewPoints: AACR19 - PARPs offer hope in pancreatic cancer.

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